Ethical and Equity Guidance for Transplant Programs Considering Thoracoabdominal Normothermic Regional Perfusion (TA-NRP) for Procurement of Hearts.

Donation after circulatory determination of death (DCDD) is an accepted practice in the United States, but heart procurement under these circumstances has been debated. Although the practice is experiencing a resurgence due to the recently completed trials using ex vivo perfusion systems, interest in thoracoabdominal normothermic regional perfusion (TA-NRP), wherein the organs are reanimated in situ prior to procurement, has raised many ethical questions. We outline practical, ethical, and equity considerations to ensure transplant programs make well-informed decisions about TA-NRP. We present a multidisciplinary analysis of the relevant ethical issues arising from DCDD-NRP heart procurement, including application of the Dead Donor Rule and the Uniform Definition of Death Act, and provide recommendations to facilitate ethical analysis and input from all interested parties. We also recommend informed consent, as distinct from typical "authorization," for cadaveric organ donation using TA-NRP.

Toward Transparency and Trust: Assessing and Addressing Key Ethical Concerns in Normothermic Regional Perfusion.

Normothermic Regional Perfusion, or NRP, is a method of donated organ reperfusion using cardiopulmonary bypass or a modified extracorporeal membrane oxygenation (ECMO) circuit after circulatory death while leaving organs in the dead donor's corpse. Despite its potential, several key ethical issues remain unaddressed by this technology.

The unique moral permissibility of uncontrolled lung donation after circulatory death.

Implementing uncontrolled donation after circulatory determination of death (uDCDD) in the United States could markedly improve supply of donor lungs for patients in need of transplants. Evidence from US pilot programs suggests families support uDCDD, but only if they are asked permission for using invasive organ preservation procedures prior to initiation. However, non-invasive strategies that confine oxygenation to lungs may be applicable to the overwhelming majority of potential uDCDD donors that have airway devices in place as part of standard resuscitation. We propose an ethical framework for lung uDCDD by: (a) initiating post mortem preservation without requiring prior permission to protect the opportunity for donation until an authorized party can be found; (b) using non-invasive strategies that confine oxygenation to lungs; and (c) maintaining strict separation between the healthcare team and the organ preservation team. Attempting uDCDD in this way has great potential to obtain more transplantable lungs while respecting donor autonomy and family wishes, securing public support, and enabling authorized persons to affirm or cease preservation decisions without requiring evidence of prior organ donation intent. It ensures prioritization of life-saving, the opportunity to allow willing donors to donate, and respect for bodily integrity while adhering to current ethical norms.

Explotación y bioética. Ética individual y regulación jurídica / Exploitation and bioethics. Individual ethics and legal regulation

En este artículo discuto los contratos o transacciones explotativas en bioética. El caso más problemático teóricamente parece ser el de lo que Allan Wertheimer llama explotación «mutuamente ventajosa»: el consentimiento de la parte débil (D) para realizar la transacción es un consentimiento efectivo y racional. Además, D no sufre un daño mediante la transacción, sino que, por el contrario, esta transacción lo beneficia en comparación con no realizar la transacción. Mi objetivo en este trabajo es, por un lado, presentar, desde el punto de vista de la ética individual, un modelo para pensar la naturaleza de la incorrección que podemos asignarle a la conducta de la parte fuerte al contratar con D en forma explotativa. En segundo lugar, ofrezco algunas razones por las cuales, en el plano de la ética jurídica, la prohibición jurídica de este tipo de conductas explotativas es problemática y sólo podría ser justificada en casos muy excepcionales

In this paper, I discuss exploitative transactions in bioethics. The most problematic case is what Allan Wertheimer calls «mutually advantageous» exploitation: the weak party’s (W’s) consent for the transaction is an effective and rational consent. Moreover, W does not suffer any harm by the transaction; on the contrary, the transaction benefits W. My aim in this paper is twofold. From the perspective of individual ethics, I offer a model to conceive the nature of the wrongfulness of strong party’s action. From the perspective of legal ethics, I suggest some reasons to believe that the prohibition of beneficial, exploitative, contracts is problematic and can only be justified in very exceptional cases

Report of the clinical donor case workshop of the European Association of Tissue Banks Annual Congress 2013.

The European Association of Tissue Banks (EATB) Donor Case Workshop is a forum held within the program of the EATB Annual Congress. The workshop offers an opportunity to discuss and evaluate approaches taken to challenging donor selection and donation ethics, and it strengthens networking between tissue banking professionals. The workshops actively engage participants from a wide array of international expertise, in an informal, secure and enjoyable setting in which learning from peers and finding potential solutions for submitted cases are facilitated. This report reflects some of the discussion at the Donor Case Workshop during the EATB Annual Congress in Brussels in 2013. The presented cases demonstrate that the findings, their interpretation, the resulting actions and preventive measures in the different tissue facilities are not always predictable. The varied responses from participants and lack of consensus corroborate this and clearly indicate that operating procedures do not comprehensively cover or prepare for all eventualities. For many of the issues raised there is no relevant information in the published literature. By publication of a summary of the discussions we hope to reach a wider audience, to provide information gathered at the workshop and to stimulate individuals and institutions to undertake further literature reviews or to undertake research in order to gather evidence concerning the discussed topics.

Aportes par aun estatuto de las partes separadas del cuerpo / No disponible

En este artículo el autor reflexiona sobre las implicaciones éticas y jurídicas que plantea el tratamiento que procede otorgar a las partes separadas del cuerpo humano. Así, el estatuto del cuerpo está cambiando tan rápidamente, bajo las presiones de los nuevos avances de las biotecnologías, que supone dilemas inéditos para el Derechos. Son igualmente relevantes los temas traídos por el incesante progreso de las ciencias biomédicas, que reclaman regulaciones acordes con sus implicancias en diversos ámbitos. Entre ellos el autor destaca; los logros en los campos de la biología molecular y la genética, la proliferación y diversificación de biobancos, y la comercialización y patentabilidad de genes, secuencias de genes y otros materiales biológicos, que genera una serie de problemas éticos y jurídicos (AU)

In this article the author reflects on the ethical and legal implications arising from the treatment that should be conferred on the separate parts of the human body. Thus, the status of the body is changing so rapidly, due to the new developments in biotechnology, that raises unprecedented dilemmas for the Law. Also noteworthy the relevant issues brought by the incessant progress of biomedical science, claiming regulations consistent with its implications in various fields. The following issues will be highlighted by the author: the achievements in the fields of molecular biology and genetics, the proliferation and diversification of biobanks, and the commercialization and patenting of genes, gene sequences and other biological materials, which generates a series of ethical and legal problems (AU)

Consentimiento informado para el tratamiento de la información genética en el derecho colombiano / No disponible

El conocimiento del genoma humano ha permitido el desarrollo de nuevas formas del cuidado de la salud denominadas genéricamente como medicina genómica. Sin embargo este saber no está exento de riesgos relacionados con el acceso y uso de la información genética, que involucra no solo al individuo, sino también a su familia biológica, etnia y grupo poblacional al que pertenece, afectando derechos individuales y colectivos que son objeto de protección por parte del derecho. Este artículo aborda el derecho en Colombia específicamente en lo referente al tratamiento de la información genética para el diagnóstico y tratamiento, teniendo como eje central el proceso del consentimiento informado. Para tal fin se revisaron el concepto de información genética, los riesgos y beneficios asociaos con el tratamiento de los datos genéticos, se llevó a cabo la descripción y el análisis crítico de la regulación en Colombia. Se concluye que el marco jurídico colombiano evidencia deficiencias respecto a la protección de derechos individuales y colectivos vinculados con el tratamiento de la información genética (AU)

Deciphering the human genome has allowed the development of new health care ways which have been generically referred to as genomic medicine. However, this new knowledge is not devoid of risks related to the access and use of genetic information, involving not only the individual, but also the biological family, ethnic group and community to which he/she belong to. This affects both individual and collective rights, which must be protected by law. This manuscript reviews the Colombian law, specifically in terms of the access and use of genetic information for diagnostic and treatment purposes, focusing on the informed consent process. The concept of genetic information, the risks and benefits associated with genetic data management and the description and critical analysis of the present Colombian regulations were thus reviewed. As a conclusion, the juridical framework of Colombia shows deficiencies regarding the protection of both individual and collective rights linked to the access and use of genetic information (AU)

Presumed consent for organ preservation in uncontrolled donation after cardiac death in the United States: a public policy with serious consequences.

Organ donation after cessation of circulation and respiration, both controlled and uncontrolled, has been proposed by the Institute of Medicine as a way to increase opportunities for organ procurement. Despite claims to the contrary, both forms of controlled and uncontrolled donation after cardiac death raise significant ethical and legal issues. Identified causes for concern include absence of agreement on criteria for the declaration of death, nonexistence of universal guidelines for duration before stopping resuscitation efforts and techniques, and assumption of presumed intent to donate for the purpose of initiating temporary organ-preservation interventions when no expressed consent to donate is present. From a legal point of view, not having scientifically valid criteria of cessation of circulation and respiration for declaring death could lead to a conclusion that organ procurement itself is the proximate cause of death. Although the revised Uniform Anatomical Gift Act of 2006 provides broad immunity to those involved in organ-procurement activities, courts have yet to provide an opinion on whether persons can be held liable for injuries arising from the determination of death itself. Preserving organs in uncontrolled donation after cardiac death requires the administration of life-support systems such as extracorporeal membrane oxygenation. These life-support systems can lead to return of signs of life that, in turn, have to be deliberately suppressed by the administration of pharmacological agents. Finally, allowing temporary organ-preservation interventions without expressed consent is inherently a violation of the principle of respect for a person's autonomy. Proponents of organ donation from uncontrolled donation after cardiac death, on the other hand, claim that these nonconsensual interventions enhance respect for autonomy by allowing people, through surrogate decision making, to execute their right to donate organs. However, the lack of transparency and the absence of protection of individual autonomy, for the sake of maximizing procurement opportunities, have placed the current organ-donation system of opting-in in great jeopardy. Equally as important, current policies enabling and enhancing organ procurement practices, pose challenges to the constitutional rights of individuals in a pluralistic society as these policies are founded on flawed medical standards for declaring death.

Bodies, organs and saving lives: old respects and new dilemmas.

Attitudes to death are non-rational and culturally determined. This is relevant to concerns about shortages of organs for transplantation. Consent is not possible from a dead donor and the term 'resumed consent' offends against the principle of respect for autonomy that underpins consent. Consent is the fundamental principle of the Human Tissue Act 2004 in considering use of organs after death. These legal and ethical concerns create difficulties to be explored in a subsequent paper.